(27 days)
The CLS™ Spotorno™ Femoral Stem is intended for cementless use in total hip replacement in treatment of the following:
- patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis and conditions of inflammatory degenerative joint disease (IJD), e.g. rheumatoid arthritis;
- those patients with failed previous surgery where pain, deformity, or dysfunction persists;
- revision of previously failed hip arthroplasty.
The CLS™ Spotorno™ Femoral Stem is intended for use as a prosthetic replacement of the proximal portion of the femur during total hip arthroplasty. This Special 510(k) incorporates the following changes as compared to the original device configuration: 1) addition of the CLS 125° stem, with an increased offset; and 2) incorporation of a slim neck and short taper. Below the resection line, the design of the modified stem remains the same as the legally marketed device.
The provided text describes a medical device submission, specifically a Special 510(k) for a modified femoral stem (CLS™ Spotorno™ Stem). The core of the provided information relates to the fatigue testing of this device to ensure it continues to meet safety and effectiveness standards after modifications.
Here's an analysis of the acceptance criteria and study as per your request:
Acceptance Criteria and Study Details for the CLS™ Spotorno™ Femoral Stem
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Survive physiological loading (fatigue testing) | All test samples met the acceptance criteria, thus indicating that the device, as modified, will survive physiological loading. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states "All test samples" but does not specify the exact number of samples used for fatigue testing.
- Data Provenance: The study was conducted by the manufacturer, Zimmer Austin, Inc. and Zimmer GmbH. The data is prospective, generated specifically for this 510(k) submission to demonstrate the safety and effectiveness of the modified device. The country of origin for the testing would be where Zimmer GmbH (Switzerland) or Zimmer Austin, Inc. (USA) conducted the tests, which is not explicitly stated but implied to be within the manufacturer's quality system.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This study involves mechanical fatigue testing, not a clinical study where expert ground truth on patient data would be established. The "ground truth" here is the physical performance of the device under simulated physiological loading conditions as defined by engineering standards for orthopedic implants.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is mechanical testing, not a clinical study requiring expert adjudication of observations. The "adjudication" is based on whether the test samples pass or fail the predetermined engineering acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a submission for a medical device (femoral stem) based on mechanical testing (fatigue testing), not an AI-enabled diagnostic or imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The "standalone" performance here refers to the physical device itself (the femoral stem) undergoing mechanical testing without human interaction or an AI algorithm involved in its function or assessment during the test. The "algorithm" would be the engineering specifications and test protocols that determine acceptance.
7. The Type of Ground Truth Used
The ground truth used is derived from engineering standards and predetermined mechanical performance criteria for orthopedic implants, specifically for fatigue strength under physiological loading. These standards are typically established by regulatory bodies (e.g., ISO, ASTM) and industry best practices to ensure the long-term durability and safety of the implant.
8. The Sample Size for the Training Set
Not applicable. There is no AI algorithm being "trained" in this context. The study is a mechanical verification of a physical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there's no AI training set, there's no ground truth for it to be established.
{0}------------------------------------------------
SEP 1 5 2004 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
- Zimmer Austin, Inc. Submitter: 9900 Spectrum Drive Austin, TX 78717 (512) 432-9255
- Zimmer GmbH Manufacturer: Sulzer Allee 8 Winterthur, 8404 Switzerland
- August 16, 2004 Date:
- Contact Person: Audrey Swearingen Manager, Regulatory Affairs
- Hip joint metal/ceramic/polymer semi-constrained cemented or Classification Name: nonporous uncemented prosthesis 21CFR 888.3353
- Common/Usual Name: Femoral Stem
- CLS™ Spotorno™ Stem Trade/Proprietary:
Product Description:
The CLS™ Spotorno™ Femoral Stem is intended for use as a prosthetic replacement of the proximal portion of the femur during total hip arthroplasty. It is indicated for cementless use in total hip replacement in treatment of the following:
- patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. + avascular necrosis, osteoarthritis and conditions of inflammatory degenerative joint disease (IJD), e.g. rheumatoid arthritis;
- those patients with failed previous surgery where pain, deformity, or dysfunction � persists;
- revision of previously failed hip arthroplasty �
This Special 510(k) incorporates the following changes as compared to the original device configuration: 1) addition of the CLS 125° stem, with an increased offset; and 2) incorporation of a slim neck and short taper. Below the resection line, the design of the modified stem remains the same as the legally marketed device.
Substantial Equivalence:
The modified CLS™ Spotorno™ Stem is substantially equivalent in terms of fundamental design, materials, manufacturing, indications for use and intended use to the previously cleared, currently marketed CLS™ Stems.
Verification activities included fatigue testing of the CLS 125° to ensure that the modified design is safe and effective. All test samples met the acceptance criteria, thus indicating that the device, as modified, will survive physiological loading.
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its wings, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 5 2004
Ms. Audrey Swearingen Manager, Regulatory Affairs Zimmer Austin, Inc. 9900 Spectrum Drive Austin, TX 78717
K042249 Re: Trade/Device Name: CLSTM Spotorno™ Femoral Stem Regulatory Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO Dated: August 18, 2004 Received: August 19, 2004
Dear Ms. Swearingen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rollowed your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use bated in the eners of 776, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, do noo that hat to other hat do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set of the rate 877, accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{2}------------------------------------------------
Page 2 – Ms. Audrey Swearingen
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and w yourse of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire spocific acries in 101 (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other golderal informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known): __ ҚоЧ2249
Device Name: CLS™ Spotorno™ Stem
Indications for Use:
The CLS™ Spotorno™ Femoral Stem is intended for cementless use in total hip replacement in treatment of the following:
- patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular � pations osteoarthritis and conditions of inflammatory degenerative joint disease (IJD), e.q. rheumatoid arthritis;
- e.g. Treathator artimal �
- revision of previously failed hip arthroplasty. �
Prescription Use
(Part 21 CFR 801 Subpart D) X
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page of of a
510(k) Number K042249
(Posted November 13, 2003)
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.